Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-02 @ 6:22 PM
Study NCT ID:
NCT00978094
Status:
COMPLETED
Last Update Posted:
2010-11-17
First Post:
2009-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Novel Sham Cervical Spinal Manipulation Procedure
Sponsor:
Canadian Memorial Chiropractic College
Organization:
Study Overview
Official Title:
Validation of a Novel Sham Cervical Spinal Manipulation Procedure.
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary hypotheses:
Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
2. there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
2. there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
Detailed Description:
1. Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
2. Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
3. Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
4. Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
2. Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
3. Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
4. Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21AT004396-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |